EN

Official Journal of the European Union

C 209/32

(Case T-223/20)

(2020/C 209/44)

Language of the case: English

Parties

Applicant: Orion Oyj (Espoo, Finland) (represented by: C. Schoonderbeek, lawyer, J. Mulryne and E. Amos, Solicitors)

Defendant: European Commission

Form of order sought

The applicant claims that the Court should:

—annul the decision of the defendant dated 13 February 2020 to grant a generic marketing authorisation for ‘Dexmedetomidine Accord’;

—order the defendant to pay the applicant’s legal and other costs and expenses in relation to this matter.

Pleas in law and main arguments

In support of the action, the applicant relies on three pleas in law.

1.First plea in law, alleging that the contested decision constitutes a violation of Article 10(1) of Directive 2001/83/EC, (1) read in conjunction with Article 10(2)(a) thereof, by accepting the medicinal product ‘Precedex’, which was granted a national marketing authorisation in the Czech Republic prior to accession to the EU as a reference medicinal product, given that this national marketing authorisation was not granted (or updated) in accordance with Union provisions in force.

2.Second plea in law, alleging that the contested decision constitutes a violation of Article 14(11) of Regulation 726/2004, (2) read in conjunction with Article 10(1) and 6(1) of Directive 2001/83, by concluding that the regulatory data protection for the applicant’s product, ‘Dexdor’, had expired and accepting that it (and the research data underlying it) could be used as a reference medicinal product in support of an application for a marketing authorisation for a copy (generic) product, on the grounds that the medicinal product ‘Precedex’ and ‘Dexdor’ belong to the same global marketing authorisation.

3.Third plea in law, alleging that the contested decision does not contain an adequate statement of reasons as required by Article 296 TFEU.

(1) Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use (OJ 2001 L 311, p. 67).

(2) Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and surveillance of medicinal products for human and veterinary use and establishing a European Medicines Agency (OJ 2004 L 136, p. 1).